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Senolytic
Senolytic Therapy for Frailty
Phase 2
Recruiting
Led By Gregory T. Armstrong, MD, MSCE
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant in SJLIFE and > 5 years from diagnosis
CD3+ T lymphocytes: p16^INK4A detected at <33 cycles by RT PCR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 150
Awards & highlights
Study Summary
This trial will test two different senolytic therapies to see if they are effective in reducing senescent cells and improving frailty. The primary endpoints are change in walking speed and senescent cell abundance.
Who is the study for?
Adults who survived childhood cancer and are now frail (meeting at least 3 of 5 specific health criteria), over 18 years old, more than 5 years post-diagnosis, with certain blood markers. They must be able to take oral meds, not pregnant or nursing, agree to use contraception due to teratogenic risks of Dasatinib, have no severe heart issues or anemia, and not on conflicting medications.Check my eligibility
What is being tested?
The trial is testing two treatments aimed at reducing cell aging and improving physical function in adult survivors of childhood cancer. One group will receive a combination of drugs called Dasatinib plus Quercetin; the other will get Fisetin alone. The main goals are better walking speed and fewer senescent cells in the blood.See study design
What are the potential side effects?
Possible side effects include increased risk for infections due to weakened immune system responses from Dasatinib; gastrointestinal issues like nausea or diarrhea; potential allergic reactions; fatigue; changes in liver enzymes which might indicate liver damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am part of SJLIFE and was diagnosed over 5 years ago.
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My test shows low levels of a specific protein in my immune cells.
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I am 18 years old or older.
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I am considered frail due to issues with walking speed, muscle strength, activity level, muscle mass, and fatigue.
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My hemoglobin level is above the required minimum for my gender.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 150
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 150
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Walking Speed
Change in walking speed
Senescent cell abundance in blood (p16INK4A)
Secondary outcome measures
Safety of two different senolytic therapies as assessed by treatment-related adverse events using CTCAE v5.0
Tolerability of two different senolytic therapies as assessed by treatment-related adverse events using CTCAE v5.0
Trial Design
2Treatment groups
Active Control
Group I: Dasatinib plus QuercetinActive Control1 Intervention
Day 0 (30 per arm, randomization stratified by sex and age)
At the visit on day 7, blood CD3+ T lymphocyte p16^INK4A mRNA and other markers of inflammation and senescence will be accessed to verify that senescent cells have been cleared by the intervention.
Post-treatment follow-up will occur on days 60 for (primary endpoints) and day 150 for secondary evaluation. Day 150 will assess the permanence of change after completion of the trial.
Group II: FisetinActive Control1 Intervention
Day 0 (30 per arm, randomization stratified by sex and age)
At the visit on day 7, blood CD3+ T lymphocyte p16INK4A mRNA and other markers of inflammation and senescence will be accessed to verify that senescent cells have been cleared by the intervention.
Post-treatment follow-up will occur on days 60 for (primary endpoints) and day 150 for secondary evaluation. Day 150 to will assess the permanence of change after completion of the trial.
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
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5,306,553 Total Patients Enrolled
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National Institutes of Health (NIH)NIH
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National Cancer Institute (NCI)NIH
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am part of SJLIFE and was diagnosed over 5 years ago.I am currently taking blood thinners or antibiotics.My test shows low levels of a specific protein in my immune cells.I agree to use birth control due to the medication's risk to pregnancy.I am 18 years old or older.I am not currently receiving treatment for any cancer except non-melanoma skin cancers.I cannot stop my blood thinner medication for the trial.I am considered frail due to issues with walking speed, muscle strength, activity level, muscle mass, and fatigue.My hemoglobin level is above the required minimum for my gender.I can take pills by mouth.I am currently taking Quercetin or Fisetin.I am not on medications that affect certain liver enzymes.I have HIV, Hepatitis B/C, or an invasive fungal infection.I have anemia.You are allergic to the study drugs.I have cognitive or motor issues due to birth defects.I am not part of any other study to improve walking or reduce frailty.I have fluid buildup that isn't being managed around my lungs or heart, or in my abdomen.
Research Study Groups:
This trial has the following groups:- Group 1: Dasatinib plus Quercetin
- Group 2: Fisetin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How large is the current cohort of individuals participating in this investigation?
"Affirmative, according to clinicaltrials.gov this study is still recruiting participants. It was first launched on June 6th 2022 and the most recent update occurred on June 8th of that same year. 60 volunteers are sought from a single medical centre for inclusion in the trial."
Answered by AI
Is there any potential harm associated with the use of Fisetin?
"Based on the available evidence, our team at Power assigned a rating of 2 for Fisetin's safety. This is because this drug has only completed Phase 2 trials and there are limited data regarding its efficacy."
Answered by AI
Are opportunities still available to join this medical investigation?
"Affirmative. The information posted on clinicaltrials.gov confirms the recruitment process of this medical study, which was published on June 6th 2022 and recently updated two days later. Approximately 60 participants are being sought from 1 particular site."
Answered by AI
Could you elucidate the other research projects that have utilized Fisetin?
"Currently, 72 investigations pertaining to the effectiveness of Fisetin are in progress. 9 of these ongoing trials have reached Phase 3 and most are situated in New york City, with 4266 locations across the USA running studies for this medication."
Answered by AI
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